Efficacy of Spinal Oxytocin in Healthy Volunteers

Phase 2

Terminated

• Conditions: Healthy Volunteer Study
• Interventions: Drug: Placebo; Drug: Oxytocin 150 mcg; Drug: Oxytocin 15 mcg

• Registration Number: NCT01996605
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

The purpose of this study is to determine the effect of intrathecal oxytocin on areas and intensity of hyperalgesia and allodynia induced by topical capsaicin.

Detailed Description

Purpose: There is a strong experimental basis to support the study of oxytocin by the spinal route for analgesia in humans. Oxytocin containing cells in the dorsal parvocellular division of the paraventricular nucleus (PVN) project to the spinal cord (1). Noxious stimulation activates these cells via the A1 noradrenergic relay in the pons (2) and produces analgesia by spinal release of oxytocin, since intrathecal injection of an oxytocin receptor antagonist worsens pain behaviors from peripheral inflammation (3). Direct electrical stimulation of the PVN reduces dorsal horn neuronal responses to noxious stimulation, and this is blocked by administration of sequestering antibody for oxytocin (4). Similarly, direct electrical stimulation of the PVN reduces behavioral sensitivity in a model of chronic neuropathic pain, and this effect is blocked by an oxytocin receptor antagonist (5). Intrathecal injection of oxytocin in normal rats reduces dorsal horn neuronal responses to noxious stimuli (6) as well as behavioral responses to noxious thermal (3), mechanical (3), and chemical (7) stimuli. Finally, intrathecal injection of oxytocin in rat models of chronic pain also reduces dorsal horn neuronal responses to sensory stimulation (6) as well as behavioral responses to thermal (5) and mechanical (7) stimuli.

Rationale: We anticipate that oxytocin will be effective after spinal injection in humans against chemical induced hypersensitivity states.

Objectives: Determine the effect of intrathecal oxytocin on areas and intensity of hyperalgesia and allodynia induced by topical capsaicin.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-27
• Study Start: 2014-01-02
• Primary Completion: 2022-10-10
• Study Completion: 2022-10-10
• Status Verified: 2022-11
• Results First Submitted: 2023-08-07
• Results First Submitted QC: 2023-08-31
• Last Update Submitted: 2023-08-31
• Results First Posted: 2023-09-14
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• healthy
• weight < 240 pounds
• American Society of Anesthesiology Category 1 or 2

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Exclusion Criteria

• allergy to oxytocin or lidocaine
• allergy to chilli peppers
• Females: active gynecological disease such as uterine fibroids or ongoing bleeding
• Pregnancy or currently breastfeeding
• Females that have delivered a baby within 2 years of study
• Taking prescription medications (exception: oral birth control medication)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Preservative free normal saline injected spinally
Oxytocin 150 mcg	Oxytocin 150 mcg	Oxytocin 150 mcg injected spinally
Oxytocin 15 mcg	Oxytocin 15 mcg	Oxytocin 15 mcg injected spinally

Primary Outcome Measures

Name	Time	Method
Hyperalgesia	105 minutes after study drug injection	The area of hyperalgesia after the first skin heating following topical capsaicin.

Trial Locations

Locations (1)

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States